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ISO 5841-2:2014 (R2019)
Implants for surgery — Cardiac pacemakers
Part 2: Reporting of clinical performance of populations of pulse generators or leads
Part 2: Reporting of clinical performance of populations of pulse generators or leads
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Summary
ISO 5841-2:2014 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.
Notes
90.20 : Norme internationale en cours d'examen systématique
Technical characteristics
| Publisher | International Organization for Standardization (ISO) |
| Publication Date | 07/29/2014 |
| Confirmation Date | 12/12/2019 |
| Edition | 3 |
| Page Count | 26 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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29/07/2014
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